Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

NCT01532648 on ClinicalTrials.gov Phase 3 Bausch Health Americas, Inc. (industry) Started 2012-01-27 Completed

Riskier than 51% of active trials

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (213 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2013-10-02, after 2012-01-27 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2013-10-02. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: randomizationcellsulntherapyactive
Phrases that lowered it: participantsparticipantand safetyefficacy andscreening
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 56.1% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 6.5% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: quadruple (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 95 (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 14 (raises risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: 75 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 95 (typical: 32)
Sponsor's past termination rate: 5.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 14 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 17248 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5306 (typical: 412.5)
Drug's FAERS reports marked serious: 56.1% (typical: 85.6%)
Drug's FAERS reports with a death: 6.5% (typical: 15.9%)

Disease area and drugs

Disease areas: digestive
Drugs matched to FDA substances: budesonide

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis NCT00679432 · started 2008 · scored riskier than 19% of active trials completed
(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets NCT01100112 · started 2010 · scored riskier than 10% of active trials completed
(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis NCT00679380 · started 2008 · scored riskier than 14% of active trials completed
A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis NCT01805791 · started 2013 · scored riskier than 68% of active trials terminated
Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis NCT01671956 · started 2015 · scored riskier than 49% of active trials terminated

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.